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Today’s topic is “Antibiotic Stewardship

Program Implementation”10/25/17

Antibiotic Stewardship Program Implementation

Robin Jump, MD, PhD

Cleveland Geriatric Research Education and Clinical Center (GRECC)Louis Stokes Cleveland VA Medical Center

Case Western Reserve University

Robin.Jump@va.gov or robinjump@gmail.com

Speaker Disclosures

Dr. Jump has no direct conflicts of interest related to this presentation.

Dr. Jump has current research support from Steris, the VA, CDC and AHRQ. She has previously consulted for GOJO and Pfizer.

The opinions presented herein are my own and do not represent those of the Veterans Affairs system or the federal government.

Learning Objectives

Photo: Ulrich Joho

• Review the Center for Medicare & Medicaid Conditions of Participation for an antibiotic stewardship program in long-term care facilities (LTCFs).

• Discuss successful antibiotic stewardship interventions in LTCFs.

• Describe strategies for implementing antibiotic stewardship in LTCFs

Search on September 25th, 2017

Search on September 25th, 2017

https://www.federalregister.gov/documents/2016/10/04/2016-23503/medicare-and-medicaid-programs-reform-of-requirements-for-long-term-care-facilities

https://www.federalregister.gov/documents/2016/10/04/2016-23503/medicare-and-medicaid-programs-reform-of-requirements-for-long-term-care-facilities

185 pages;Search for specific terms using Ctrl-F or ⌘-F

Page 181

Search on August 13th, 2017

Reform of Requirements

https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/GuidanceforLawsAndRegulations/Nursing-Homes.html

Reform of Requirements

https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/GuidanceforLawsAndRegulations/Nursing-Homes.html

Department of Health & Human CMS Manual System Services (DHHS)

Centers for Medicare & Medicaid Pub. 100-07 State Operations Services (CMS)

Provider Certification Transmittal 169- Advanced Date:

Copy

SUBJECT: Revision to State Operations Manual (SOM) Appendix PP for Phase 2, F-Tag

Revisions, and Related Issues

I. SUMMARY OF CHANGES: The revisions to the Centers for Medicare & Medicaid

Services (CMS) Requirements for Participation under the Medicare and Medicaid

Programs; Reform of Requirements for Long-Term Care Facilities Final Rule caused

many of the prior regulatory citations to be re-designated. As such, CMS was required to

re-number the F-Tags used to identify each regulatory part. Those new F-Tags are

described here

NEW/REVISED MATERIAL - EFFECTIVE DATE: Month XX, 2017

IMPLEMENTATION: Month XX,, 2017

Disclaimer for manual changes only: The revision date and transmittal number apply to the

red italicized material only. Any other material was previously published and remains

unchanged. However, if this revision contains a table of contents, you will receive the

new/revised information only, and not the entire table of contents.

II. CHANGES IN MANUAL INSTRUCTIONS: (N/A if manual not updated.)

(R = REVISED, N = NEW, D = DELETED) – (Only One Per Row.)

R/N/D CHAPTER/SECTION/SUBSECTION/TITLE

R Entire Appendix, New F-Tags

III. FUNDING: No additional funding will be provided by CMS; contractor activities are

to be carried out within their FY 2016 operating budgets.

IV. ATTACHMENTS:

Business Requirements

X Manual Instruction

Confidential Requirements

One-Time Notification

Recurring Update Notification

*Unless otherwise specified, the effective date is the date of service.

Effective November 28, 2017

State Operations Manual

State Operations Manual Appendix PP - Guidance to Surveyors for

Long Term Care Facilities Table of Contents

(Rev. XXX, XX-XX-17)

Transmittals for Appendix PP

INDEX

§483.5 Definitions

§483.10 Resident Rights

§483.12 Freedom from Abuse, Neglect, and Exploitation

§483.15 Admission Transfer and Discharge Rights

§483.20 Resident Assessment

§483.21 Comprehensive Person-Centered Care Planning

§483.24 Quality of Life

§483.25 Quality of Care

§483.30 Physician Services

§483.35 Nursing Services

§483.40 Behavioral health services

§483.45 Pharmacy Services

§483.55 Dental Services

§483.60 Food and Nutrition Services

§483.65 Specialized Rehabilitative Services

§483.70 Administration

§483.75 Quality Assurance and Performance Improvement

§483.80 Infection Control

§483.85 Compliance and Ethics Program

§483.90 Physical Environment

§483.95 Training Requirements

Organization

• F-tag for specific sections (§)

• Definitions

• Intent

• Guidance

• Procedures and Probes

• Investigative Protocol

• Key Elements of Non-Compliance

• Deficiency Categories

“stewardship”

• F881 on page 655 for

§483.80(a)(3)

• F690 on page 312-313

F690—Incontinence;

starts on page 301;

§483.25(e).

• F880 on page 633

F880—Infection Control;

starts on page 628;

§483.80(a)(e)(f).

Intent (page 655)

• Develops and implements protocols to optimize the treatment of infections by ensuring that residents who require an antibiotic, are prescribed the appropriate antibiotic;

• Reduces the risk of adverse events, including the development of antibiotic-resistant organisms, from unnecessary or inappropriate antibiotic use; and

• Develops, promotes, and implements a facility-wide system to monitor the use of antibiotics.

https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/GuidanceforLawsAndRegulations/Downloads/Advance-Appendix-PP-Including-Phase-2-.pdf

Guidance(page 656)

Facilities must develop an antibiotic stewardship program that

promotes the appropriate use of antibiotics and

includes a system of monitoring to improve resident outcomes and reduce antibiotic resistance

This means that the antibiotic is prescribed for the correct indication, dose, and duration to appropriately treat the resident while also attempting to reduce the development of antibiotic-resistant organisms

CDC’s Core Elements (page 657)

• Leadership commitment• Accountability• Drug expertise• Action• Tracking• Reporting• Education

https://www.cdc.gov/longtermcare/prevention/antibiotic-stewardship.html

Protocols Must Monitor Use... (page 658)

Incorporate monitoring of antibiotic use, including the frequency of monitoring/review.

Review when the resident is • new to the facility• returns or is transferred from a hospital or other facility• during each monthly medication review

Protocols Must Also... (page 658)

• Assess residents for any infection using standardized tools and criteria

• Contain a system of reports related to monitoring antibiotic usage and resistance data.

• Educate prescribing practitioners and nursing staff on antibiotic use (stewardship) and the facility’s antibiotic use protocols.

Record how it’s done (verbal, online etc.)

Record how often

Protocols Must Give Feedback... (page 658)

Give feedback to prescribing practitioners regarding

• antibiotic resistance data• their antibiotic use and• their compliance with facility antibiotic use protocols

Record how and when feedback is given.

Investigative Summary (page 659)

Do protocols address antibiotic prescribing practices?

• Documentation of the indication, dose, and duration of the antibiotic

• Review of laboratory reports to determine if the antibiotic is indicated or needs to be adjusted;

• An infection assessment tool or management algorithm is used when prescribing

Is there a system to monitor antibiotic use (i.e., antibiotic use reports, antibiotic resistance reports)?

Key Elements of Non-Compliance page 659

Failure to develop and implement antibiotic use protocols that

• help ensure that residents who require antibiotics are prescribed the appropriate antibiotics;

• that address unnecessary or inappropriate antibiotic

Develop, promote and implement a facility-wide system to monitor the use of antibiotics.

Examples of Deficiencies(page 659-60)

Immediate Jeopardy:• Results of microbiological culture

(indicating resistant bacteria) not communicated to practitioner; antibiotic not changed; resident hospitalized for complications

Actual Harm:• No protocols or monitoring system. 2

residents on antibiotics without appropriate indication. Both developed C. difficile infection.

Potential Tags For Additional Investigation

page 660

• Additionally, refer to §483.45(c), F756, for concerns related to the failure of the pharmacist to review and report any unnecessary antibiotic irregularity and §483.45(d), F757, for concerns related to unnecessary antibiotic use.

• Refer to 483.10(c)(1), 483.10(c)(4)‐(6):–the right to be fully informed in advance about care and treatment (F552) for concerns about education of residents and their representatives.

Learning Objectives

Photo: Ulrich Joho

• Review the Center for Medicare & Medicaid Conditions of Participation for an antibiotic stewardship program in long-term care facilities (LTCFs).

• Discuss successful antibiotic stewardship interventions in LTCFs.

• Describe strategies for implementing antibiotic stewardship in LTCFs

Review of Antimicrobial Stewardship in LTCFs

• 20 studies with quantitative outcomes• 5 randomized controlled trials• 15 quasi-experimental analyses

• Quality: 11 good, 7 fair, 2 poor

• 14 with measurable changes• Reduced antibiotic starts• Reduced total antimicrobial use• Increased adherence to guidelines• Reduce incidence of C. difficile infection

and rates of drug-resistant bacteriaKatz et al. Clinical Infectious Diseases 2017

Work System

Holden et al. Ergonomics 2013 Nov 56(11)

Tasks

Tools & Technologies

Organization

Environment

Person(s)

Katz et al. Clinical Infectious Diseases 2017

Component Description Example

Tools and Technology

• Objects that individuals use to carry out their work

• Alert on an electronic health record• Pocket card with antibiotic

prescribing guidelines

Tasks• Specific actions

within a larger work process

• Act of administering a medication• Daily checklist of antibiotic

monitoring criteria

Organization• Culture• Communication

between individuals.

• Incentive program for following antibiotic prescribing guidelines

• Support from stakeholders for promotion of antibiotic stewardship program

Person(s)• Characteristics of

people within the work system

• Knowledge, expertise or training of nursing home staff

• Outside consultants

Environment• Physical internal or

external environment

• Placing commitment posters in a high traffic work area

Katz et al. Clinical Infectious Diseases 2017

Component Description Example

Tools and Technology

18

• Objects that individuals use to carry out their work

• Alert on an electronic health record• Pocket card with antibiotic

prescribing guidelines

Tasks

11• Specific actions

within a larger work process

• Act of administering a medication• Daily checklist of antibiotic

monitoring criteria

Organization

9

• Culture• Communication

between individuals.

• Incentive program for following antibiotic prescribing guidelines

• Support from stakeholders for promotion of antibiotic stewardship program

Person(s)

8

• Characteristics of people within the work system

• Knowledge, expertise or training of nursing home staff

• Outside consultants

Environment

4

• Physical internal or external environment

• Placing commitment posters in a high traffic work area

2 Additional Components

Involvement of Nurses (14 studies)

Structured Education (16 studies)

• Primary intervention for 7 studies

Sustained changes• Compared local policy to published

guidelines

• Individualized feedback to providers

• Focus on UTIs (vs. asymptomatic bacteriuria)

So what works?

• Organization: Integrate change into the workflow

• Nurses—pre-prescription• Prescribers—post-

prescriptive; communication via electronic medical record

• Persons: Involve professionals with infectious disease expertise

Intervention for catheter-associated ASB*

• Intervention site: 5 acute care and 5 CLC units at a VA medical center

• Control site: 3 acute and 2 CLC units

• On CLC wards, targeted nurses and prescribers

• Case-based audit and feedback and interactive slides. Control site given didactic slides and emailed guidelines

*Asymptomatic bacteriuria

Trautner et al. JAMA Intern Med 2015;175(7):1120-7

Monthly Rates of Urine Cultures

Trautner et al. JAMA Intern

Med 2015;175(7):1120-7

Intervention for catheter-associated ASB

Trautner et al. JAMA Intern Med 2015;175(7):1120-7

Outcomes for CLC residentsBaseline(n = 208)

Intervention (n = 36)

Cases of ASB, n (%) 135 (65%) 25 (70%)

Cases of CAUTI, n (%) 73 (35%) 11 (31%)

Overtreatment of ASB 70/135 (52%) 5/25 (20%)

Undertreatment of CAUTI 9/73 (12%) 2/11 (18%)

Infectious Disease Expertise:Rounds by Consultant

• Weekly rounds by an Infectious Disease physician and NP at a VA Community Living Center (CLC)

• Communication in-person and formal recommendations, orders left in electronic medical record

• Total antibiotic use decreased by 30%

Jump et al. JAGS 2013 61(5): 782-7

35

Infectious Disease Expertise:Chart Review

Beaulac et al. ICHE 2016 37(4): 433-9• ID physicians & pharmacists reviewed daily

pharmacy reports

• Accessed electronic medical records

• Recommendations to providers via email

• Decrease in antibiotic use and CDI rates

Pate et al. ICHE 2012 33(4): 405-8• Physician and pharmacist reviewed charts

weekly. Non-binding recommendations placed in chart; not permanent part of record.

• 21% reduction in antibiotic use

Facility Culture and Antibiotic Stewardship

0

250

500

750

1000

1250

A B C D E F

NumberofAn

bio

cPrescrip

ons

NursingHome

>30days

15-29days

8-14days

4-7days

1-3days

Carter et al. JAGS 2017 May65(5): 1073-1078

0

250

500

750

1000

1250

A B C D E F

NumberofAn

bio

cPrescrip

ons

NursingHome

>30days

15-29days

8-14days

4-7days

1-3days

Carter et al. JAGS 2017 May65(5): 1073-1078

Did not respond to request for interviews

Medical Director, DON and Infection Control RN talked with us, together

0

250

500

750

1000

1250

A B C D E F

NumberofAn

bio

cPrescrip

ons

NursingHome

>30days

15-29days

8-14days

4-7days

1-3days

Carter et al. JAGS 2017 May65(5): 1073-1078

Did not respond to request for interviews

Medical Director, DON and Infection Control RN talked with us, together

“I think the providers always listen, but do they respond in the way that

maybe we were hoping for?”

0

250

500

750

1000

1250

A B C D E F

NumberofAn

bio

cPrescrip

ons

NursingHome

>30days

15-29days

8-14days

4-7days

1-3days

Carter et al. JAGS 2017 May65(5): 1073-1078

Did not respond to request for interviews

Medical Director, DON and Infection Control RN talked with us, together

“I think the providers always listen, but do they respond in the way that

maybe we were hoping for?”

“In the beginning it was kind of a scary step, [to question] a doctor.... I tell them, ‘The CDC’s recommendation isn’t that we treat for 14 days every

time now, can we cut it down a few?’ ”

Learning Objectives

Photo: Ulrich Joho

• Review the Center for Medicare & Medicaid Conditions of Participation for an antibiotic stewardship program in long-term care facilities (LTCFs).

• Discuss successful antibiotic stewardship interventions in LTCFs.

• Describe strategies for implementing antibiotic stewardship in LTCFs

Antibiotic Use Protocols

Focus on common infections and

• Diagnostic criteria

• Appropriate antibiotic choices

• Length of therapy

Use standardized assessment

criteria

Consider adapting from the Loeb

Minimum Criteria, revised McGeer

Criteria or from AHRQ websiteJump et al. JAMDA. in press

Loeb et al. ICHE 2001;22:120-124; Stone et al. ICHE 2012,33:965-977

https://www.ahrq.gov/nhguide/toolkits/determine-whether-to-treat/index.html

Measure Antibiotic Use

Metric Pros Cons

Days of Therapy (DOT): Any dose of antibiotic given on a single day per 100 (or 1000) resident days

Estimates total burden of antibiotic use.Tracks changes in overall use.

Does not measure length of treatment.Labor intensive.

Defined Daily Dose (DDD): Standardized doses of antibiotics per 100 (or 1000) resident days

World Health Organization standardized measures of antibiotics

Does not account for dose adjustments made based on age, creatinine clearance.

Antibiotic Starts: Number of new antibiotic prescriptions per month or per 100 (or 1000) resident days

Measures frequency of prescribing. Tracks changes in starts.

Does not measure total antibiotic burden or length of treatment.

Number of antibiotic prescriptions for duration >7 days per month

Tracks efforts to reduce excessive length of prescriptions.

Does not measure the frequency of overall antibiotic prescriptions.

Content adapted with permission from Dr. D. Nace

Review antibiotic prescriptions

-upon admission

-upon return from hospital or ED

-started by covering provider

-during monthly med review

Review surveillance data of resistant

bacteria

Develop an antibiogram

-may have to include only urine

Monitor Antibiotic Use and Resistance

Jump et al. JAMDA. in press

Leverage the data....

Compliance with Antibiotic Use Protocols

Measure Antibiotic Use

Monitor Antibiotic Use and Resistance

Feedback to Individuals

Feedback to Whole Facility

Education

Collect & Analyze Share

Feedback

Written reports to all staff:

Overall antibiotic use

Compliance with protocols

Surveillance data for drug-resistant

bacteria and for C. difficile

Written reports to individual providers:

Provider’s antibiotic use

Provider’s compliance with antibiotic

use protocols

Written acknowledgement of feedbackJump et al. JAMDA. in press

Example of Individualized Feedback

Reviewed and discussed:• Antibiotic Use Protocols• Antibiotic Stewardship Policy• Antibiotic Use

Metric Facility Dr. A

Antibiotic prescription with dose, duration & indication

27 of 42 (64%) 8 of 8 (100%)

Urine culture ordered for residents indication of UTI

16 of 20 (80%) 2 of 4 (50%)

Dr. A,

Sign and Date: _______________

Medical Director,

Sign and Date: _______________

Length of Therapy

1to7days

8-14days

15-28days

>28days

1to7days

8-14days

15-28days

>28days

Facility Dr. A

1to7days

8-14days

15-28days

>28days

1to7days

8-14days

15-28days

>28days

Education

Antibiotic Stewardship

-To all staff, at least annually

-Document mode & frequency

-To residents (and family members)

Antibiotic Use Protocols

-To all prescribers, medical & nursing

staff

-Document mode & frequency

Jump et al. JAMDA. in press

There’s help....

Jump et al. JAMDA. in press

• Template of an Antibiotic Stewardship Policy

• Crosswalk between the policy and specific elements in the Interpretive Guidance Document

• List of Resources to help support your efforts

Antibiotic Stewardship Haiku

Do those bugs need drugs?

Antibiotic stewardship:

Only when needed

Thank you!robinjump@gmail.com or Robin.Jump@va.gov